JOB DESCRIPTION When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Fisher Clinical Services GmbH is part of Thermo Fisher Scientific Corporation, a world-class company serving the scientific community and healthcare industry. We are leaders in providing clinical supply chain management services and clinical supplies distributed to patients worldwide. For more information about our site in Allschwil please visit: www.fisherclinicalservices.com
QA Specialist (fixed term for 1 year)
The QA Specialist, as a member of the QA Post-Approval team, is responsible for the quality review and approval of executed batch records, certificate of packaging and supporting documentation according to customer and regulatory requirements including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines as well as Fisher Clinical Services Standard Operating Procedures (SOPs).
Responsibilities:
The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH is able to provide according to quality standards and timelines. After appropriate training, the QA specialist is able to complete the following tasks:
Review of executed batch records, creation of certificate of packaging
Liasing with project managers to ensure the above mentioned documents are according to customer and regulatory requirements
Coordination and internal communication regarding the scheduling and completion of the documentation reviews and approvals
Provide support to improve documentation right first time metrics
Ensuring any deviations or quality issues are appropriately documented
Inputting or analysing data for quality metrics
Training and introduction for new team members and for other departments
Review and disposition decisions according to the agreed customer process for transport deviations and temperature excursions
Supporting the review and approval of Pharma Unit Trackwise problem reports (PRs)
Acting as a customer quality contact, answering client questions with regards to executed batch records
Your profile:
Demonstrated ability to perform detail-oriented tasks
Experience in the pharmaceutical industry, quality control/quality assurance, medication handling, scientific field or equivalent
GxP training or experience
Bachelor’s degree in science or equivalent
Excellent communication and organizational skills
Command of German and English at professional level
Ability to express detail in simple terminology, both written and verbal
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